EnergyNCT06117280
Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
A study testing Paraxanthine 200 mg and Paraxanthine 300 mg in people with Energy and Focus, run by Iovate Health Sciences International Inc at 1 site in United States.
Trial summary
Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy, Focus, Caffeine Withdrawal
- What is being tested?
- Paraxanthine 200 mg and Paraxanthine 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35
- Willing to abstain from caffeine-containing beverages and foods during the duration of the study
- Recreationally active; currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Who cannot join
- Body Mass Index: >29.9kg/m2
- Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone, etc.)
- A diagnosed medical condition under the care of a physician (e.g. type 2 diabetes) Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
- Individuals on medications known to affect caffeine metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
- Participants who are amenorrheic (females only)
- Inability to comply with the study protocol as judged by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. To assess these effects, this placebo-controlled crossover trial will compare the effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day 3 of ingestion. Participants will have a 3-day washout period before trialing the next test product/placebo.
Read the detailed description
Following enrollment to the study, participants will abstain from any products containing caffeine, for 3 days.
On the night of the 3rd day of caffeine abstinence, participants will fast overnight (~10 hours) The morning after the fast, participants will complete the Day 1 baseline questionnaire.
Participants will then consume Test Product A and complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Test Products should be consumed in a fasted state, and 1-hour post-ingestion participants will consume a standardized meal (See Section 6.3).
On Day 2, participants will consume Test Product A again but will not complete any questionnaires. The product should be consumed in a fasted state and participants will consume the standardized meal 60 minutes post-ingestion.
On Day 3, participants will consume Test Product A in a fasted state and will again consume the standardized meal 1-hour following ingestion of the product. Participants will complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Participants will then have a 3-day washout period with no products consumed or questionnaires completed.
Following the washout period, the intervention cycle will be repeated with Test Product B and, subsequently, Test Product C.
The questionnaires will consist of study-specific surveys and a cognitive assessment battery.
- Conditions
- Energy, Focus, Caffeine Withdrawal
- Being tested
- Paraxanthine 200 mg, Paraxanthine 300 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraxanthine 200 mgOther
For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
Paraxanthine 300 mgOther
For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
PlaceboOther
The placebo will contain resistant dextrin. For the three-day test cycle, participants will take one capsule per day amounting to 300mg of resistant dextrin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Dose One) | Experimental | In this crossover trial, all participants will test both active comparators and the placebo comparator. Receives: Other: Paraxanthine 200 mg |
| Intervention (Dose Two) | Experimental | In this crossover trial, all participants will test both active comparators and the placebo comparator. Receives: Other: Paraxanthine 300 mg |
| Placebo | Placebo comparator | In this crossover trial, all participants will test both active comparators and the placebo comparator. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle]
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Double Trouble" is a 90-second timed test. Based on a classic Stroop test, Double Trouble measures selective attention, processing speed, and the brain's ability to focus on specific information when presented with conflicting and layered stimuli.
Measured: 18 days
Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle]
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Feature Match" is a 90-second timed test. Feature Match is a focus and processing task that requires surveying an increasingly difficult array of information and rapidly assessing the correct response while holding previously processed and detailed information in attention.
Measured: 18 days
Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle]
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Grammatical Reasoning" is a 90-second timed test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Variation between text and shapes on screen requires holding key information in short-term memory to properly complete the task, leveraging the same parts of the brain that enable an individual to remain focused between varied stimuli.
Measured: 18 days
Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle]
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Digit Span is a 3-4 minute performance based test. Increasing in length after each successful attempt, Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly, thereby showing cognitive flexibility and the brain's ability to perform memory and attention-related tasks without error.
Measured: 18 days
Secondary outcomes (1)
Occurence of the side effects of caffeine withdrawal. [Baseline to Endline]
Decrease in symptoms of caffeine withdrawal including jitters, fatigue, drowsiness, irritability, "brain fog", and low alertness. This will be reported via participant-reported questionnaires. Incidence and severity of side effects will be reported using a Likert scale (0-5 point scale) with 0=least severe and 5=most severe.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start18 Jul 2023
- Primary completion18 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iovate Health Sciences International Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117280
- Sponsor's protocol ID
- 20329
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT06117280
- Acronym / sponsor ID
- 20329
- Conditions
- Energy, Focus, Caffeine Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Iovate Health Sciences International IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. To assess these effects, this placebo-controlled crossover trial will compare the effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day 3 of ingestion. Participants will have a 3-day washout period before trialing the next test product/placebo.
Detailed description
Following enrollment to the study, participants will abstain from any products containing caffeine, for 3 days.
On the night of the 3rd day of caffeine abstinence, participants will fast overnight (~10 hours) The morning after the fast, participants will complete the Day 1 baseline questionnaire.
Participants will then consume Test Product A and complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Test Products should be consumed in a fasted state, and 1-hour post-ingestion participants will consume a standardized meal (See Section 6.3).
On Day 2, participants will consume Test Product A again but will not complete any questionnaires. The product should be consumed in a fasted state and participants will consume the standardized meal 60 minutes post-ingestion.
On Day 3, participants will consume Test Product A in a fasted state and will again consume the standardized meal 1-hour following ingestion of the product. Participants will complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Participants will then have a 3-day washout period with no products consumed or questionnaires completed.
Following the washout period, the intervention cycle will be repeated with Test Product B and, subsequently, Test Product C.
The questionnaires will consist of study-specific surveys and a cognitive assessment battery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention (Dose One) | Experimental | Other: Paraxanthine 200 mgIn this crossover trial, all participants will test both active comparators and the placebo comparator. |
| Intervention (Dose Two) | Experimental | Other: Paraxanthine 300 mgIn this crossover trial, all participants will test both active comparators and the placebo comparator. |
| Placebo | Placebo comparator | Other: PlaceboIn this crossover trial, all participants will test both active comparators and the placebo comparator. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18-35
- Willing to abstain from caffeine-containing beverages and foods during the duration of the study
- Recreationally active; currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Key exclusion criteria (8 listed)
- Body Mass Index: >29.9kg/m2
- Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone, etc.)
- A diagnosed medical condition under the care of a physician (e.g. type 2 diabetes) Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraxanthine 200 mgFor the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine. | Other | Intervention (Dose One) |
| Paraxanthine 300 mgFor the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine. | Other | Intervention (Dose Two) |
| PlaceboThe placebo will contain resistant dextrin. For the three-day test cycle, participants will take one capsule per day amounting to 300mg of resistant dextrin. | Other | Placebo |
Primary outcome
Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle]
Time frame: 18 days
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Double Trouble" is a 90-second timed test. Based on a classic Stroop test, Double Trouble measures selective attention, processing speed, and the brain's ability to focus on specific information when presented with conflicting and layered stimuli.
Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle]
Time frame: 18 days
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Feature Match" is a 90-second timed test. Feature Match is a focus and processing task that requires surveying an increasingly difficult array of information and rapidly assessing the correct response while holding previously processed and detailed information in attention.
Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle]
Time frame: 18 days
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Grammatical Reasoning" is a 90-second timed test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Variation between text and shapes on screen requires holding key information in short-term memory to properly complete the task, leveraging the same parts of the brain that enable an individual to remain focused between varied stimuli.
Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle]
Time frame: 18 days
Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Digit Span is a 3-4 minute performance based test. Increasing in length after each successful attempt, Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly, thereby showing cognitive flexibility and the brain's ability to perform memory and attention-related tasks without error.
1 secondary outcome
Occurence of the side effects of caffeine withdrawal. [Baseline to Endline]
Time frame: 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraxanthine 200 mg and Paraxanthine 300 mg in people with Energy and Focus, run by Iovate Health Sciences International Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle] (time frame: 18 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.